Tokyo, Dec. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059933) titled 'Effects of consumption of the test food on bone density' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Euglena Co., Ltd.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on bone density. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 24 weeks Test product: Test food Administration: Three capsules/pack/day Interventions/Control_2 - Duration: 24 weeks Test product: Placebo food Administration: Three capsules/pack/day

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Japanese 2. Women 3. Adults 4. Healthy participants 5. Participants who are menopause for at least one year 6. Participants who have 70% or more young adult mean (YAM) values bone density of lumbar vertebra (total amount) Key exclusion criteria - Participants who 1. have osteoporosis 2. have taken medicines for osteoporosis 3. are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction 4. have a pacemaker or an implantable cardioverter defibrillator 5. are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. receive hormonal therapy 7. are heavy smokers (generally smoking 21 or more cigarettes per day) 8. consume excessive alcohol {generally drinking 60 g or more of pure alcohol per day (3 go of sake, 3 medium bottles of beer (1,500 mL), 2 go of shochu, or about 5 glasses of wine (about 600 mL) at least 6 days per week} 9. have extremely irregular eating habits or irregular life rhythms due to shift work, late-night work, or other factors 10. may experience significant changes (e.g., relocation, job transfer, or long-term travel) in their living environment (e.g., family or work) or in their eating and exercise habits during this study 11. are taking Foods for Specified Health Uses, Foods with Functional Claims, or Food with Nutrient Function Claims (particularly those containing calcium, vitamin D or K, magnesium, isoflavones including daidzein, genistein, or equol, lactic acid bacteria other than test food, or others which affect bone metabolism) 12. are taking or using medicines (including herbal medicines) or supplements 13. are allergic to medicines or foods related to the test product 14. are taking antithrombotic drugs such as warfarin 15. are pregnant, lactating, or planning to become pregnant during this study 16. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 17. are judged as ineligible to participate in this study by the physician Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 26 Day Date of IRB - 2025 Year 11 Month 26 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2026 Year 08 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068544

Disclaimer: Curated by HT Syndication.